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What is the effect of e-cigarettes, added to individual counseling, on smoking cessation?
In this randomized clinical trial that was terminated early after enrolling 376 of a planned 486 participants, individuals randomized to nicotine e-cigarettes plus counseling, compared with counseling alone, had significantly greater 7-day point prevalence abstinence at 12 weeks (21.9% vs 9.1%, respectively), although the difference was no longer statistically significant at 24 weeks.
Interpretation is limited by early trial termination, and further research is needed regarding long-term efficacy of e-cigarettes for smoking cessation.
Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial.
To evaluate e-cigarettes with individual counseling for smoking cessation.
Design, Setting, and Participants
A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported.
Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling.
Main Outcomes and Measures
The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.
Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, –1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, –0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).
Conclusions and Relevance
Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.
ClinicalTrials.gov Identifier: NCT02417467
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Mark J. Eisenberg, MD, MPH, Divisions of Cardiology and Clinical Epidemiology, Jewish General Hospital/McGill University, 3755 Côte Sainte-Catherine Rd, Ste H-421.1, Montréal, Québec, Canada H3T 1E2 (email@example.com).
Accepted for Publication: September 5, 2020.
Author Contributions: Drs Eisenberg and Filion had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors agreed to be accountable for all aspects of the work, and ensure the accuracy and integrity of any part of the work.
Concept and design: Eisenberg, Windle, Filion.
Acquisition, analysis, or interpretation of data: Eisenberg, Hébert-Losier, Windle, Greenspoon, Brandys, Fülöp, Nguyen, Elkouri, Montigny, Wilderman, Bertrand, Bostwick, Abrahamson, Lacasse, Pakhale, Cabaussel, Filion.
Drafting of the manuscript: Eisenberg, Hébert-Losier, Windle, Filion.
Critical revision of the manuscript for important intellectual content: Eisenberg, Windle, Greenspoon, Brandys, Fülöp, Nguyen, Elkouri, Montigny, Wilderman, Bertrand, Bostwick, Abrahamson, Lacasse, Pakhale, Cabaussel, Filion.
Statistical analysis: Cabaussel, Filion.
Obtained funding: Eisenberg, Windle, Filion.
Administrative, technical, or material support: Hébert-Losier, Windle, Greenspoon, Brandys, Fülöp, Abrahamson, Lacasse.
Supervision: Eisenberg, Hébert-Losier, Greenspoon, Brandys, Fülöp, Nguyen, Elkouri, Montigny, Wilderman, Bertrand, Bostwick, Lacasse, Pakhale.
Conflict of Interest Disclosures: Dr Eisenberg reported receiving educational grants from Pfizer Inc for providing continuing medical education in cardiology. Dr Wilderman reported receiving financial compensation from Pfizer Inc for his involvement in a smoking cessation study using varenicline. Dr Filion reported receiving salary support from the Fonds de Recherche du Quebec, a William Dawson Scholar award from McGill University, and personal fees from Institut National D’excellence en Santé et Services Sociaux. No other disclosures were reported.
Funding/Support: This trial was funded by the Canadian Institutes of Health Research (CIHR; funding reference No. 133727 and 155969). Both nicotine e-cigarettes and nonnicotine e-cigarettes were purchased from NJOY Inc (Scottsdale, Arizona).
Role of the Funder/Sponsor: The CIHR and NJOY Inc had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The E3 Investigators were as follows: Nonauthor site investigators who contributed to data collection: Portsmounth Medical Clinic, Kingston, Ontario, Canada, Gregory Paul Baran, MD; Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada, Gabor Gyenes, MD, PhD; Toronto General Hospital, Toronto, Ontario, Canada, Vivek Rao, MD, PhD; and Montréal General Hospital, Montréal, Québec, Canada, Thao Huynh, MD, PhD. Data and safety monitoring board members who provided independent oversight concerning the safety of study participants and the scientific integrity of the trial: University of Calgary, Calgary, Alberta, Canada, Peter Faris, PhD (chair); University of Alberta, Edmonton, Alberta, Canada, Finlay McAlister, MD; and Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, Andrea Gershon, MD. End points evaluation committee members who provided independent adjudication of serious adverse events: Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, Ontario, Canada, Patrick R. Lawler, MD; Center for Pulmonary Vascular Disease, Azrieli Heart Center, Division of Cardiology, Jewish General Hospital, Montréal, Québec, Canada, Ali O. Abualsaud, MD; and Division of Nephrology, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada, Ratna Samanta, MD.
Additional Contributions: We thank the individuals who participated in the trial, and the study personnel involved in enrollment and follow-up. We also thank Natalie Zacchia, MPH, and Shauna McGee, MSc, for their assistance with trial initiation and coordination, as well as Kristina Wade, BSc, Samantha Lancione, BSc, and Sophie Sun, all from the Lady Davis Institute, Montréal, Québec, Canada, for assistance in maintaining the trial database. We thank Louise Pilote, MD, MPH, PhD (McGill University Health Centre, Montréal, Québec, Canada), for helpful insights during the conduct of the trial and editorial assistance with the manuscript. Dr Pilote, Ms Wade, Ms Lancione, and Ms Sun did not receive compensation for their role in this trial; each of the other named persons did receive compensation for their role in this trial.
Data Sharing Statement: See Supplement 3.
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